The intended use of the Malibu system is as a temporary or permanent posterior, noncervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use of the Malibu spinal system, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:

. degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
. severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
spondylolisthesis. ●
. trauma (i.e., fracture or dislocation),
spinal stenosis.
. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
. spinal tumor.
. pseudoarthrosis, and/or
failed previous fusion. .

The intended use and indications of the Malibu spinal system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

. degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis .
trauma (i.e., fracture or dislocation),
. spinal stenosis.
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), ◆
. tumor,
pseudarthosis, and/or .
. failed previous fusion.

Device Description

The Malibu system will include cannulated polyaxial screws, closed lateral connectors, rod connectors, precontoured rods, and countoured crossbars. All products are fabricated from titanium alloy, with the exception of the screws which have a cobalt alloy component. All products are being offered in a wide variety of different sizes. The Malibu parts in this submission are being added to the current Malibu product line, but these items are also compatible with and work in conjunction with components in the UCR system. All product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will also offer a wide variety of instruments that range from polyaxial screw drivers to bone probes. These instruments will be made from various grades of stainless steel with a few handles made from Radel and silicone. These items are supplied "NON-STERILE" and must be sterilized prior to use.

AI/ML Overview

The provided document describes the Malibu™ Spinal System, which consists of various components for spinal fixation. This submission (K061342) is an addition to an existing product line. The device is a traditional medical implant, not an AI/ML powered device. Due to this, many of the requested criteria, such as "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and "sample size for the training set," are not applicable.

Here's an analysis of the provided information, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Malibu Spinal System are based on substantial equivalence to predicate devices. This means that the device is considered safe and effective if it shares the same intended use, technological characteristics, and principles of operation as a legally marketed device, and does not raise new questions of safety or effectiveness.

The document reports that the device meets these criteria as shown in the "Comparison Analysis" table (Table 1).

Feature	Acceptance Criteria (Substantial Equivalence to Predicate Devices)	Reported Device Performance (Malibu Spinal System)
Intended Use	Similar to predicate devices	Similar
Indications for Use	Similar to predicate devices	Similar
Design	Similar to predicate devices	Similar
Cannulated Polyaxial Screws	Similar to predicate devices (various sizes)	Similar (various sizes)
Closed Lateral Connectors	Similar to predicate devices (various sizes)	Similar (various sizes)
Rod Connectors	Similar to predicate devices (various sizes)	Similar (various sizes)
Precontoured Rods	Similar to predicate devices (various sizes)	Similar (various sizes)
Contoured Crossbars	Similar to predicate devices (various sizes)	Similar (various sizes)
Material	Similar to predicate devices (Titanium alloy, Cobalt alloy)	Similar (Titanium alloy, Cobalt alloy)
Sterile	Non-sterile, similar to predicate devices	Non-sterile
Method of Sterilization	High-temperature steam, similar to predicate devices	High-temperature steam
Mechanical Strength	All products passed testing per applicable standards.	All products passed testing per applicable standards.

2. Sample Size Used for the Test Set and the Data Provenance

This is not applicable as the submission relates to a physical medical device (spinal fixation system) and not an AI/ML powered device or a study involving patient data. The "test set" in this context refers to mechanical testing according to established standards. The document states "All products passed testing per applicable standards," indicating that the devices were subjected to engineering integrity tests. Specific sample sizes for such mechanical tests are not detailed in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable for a physical medical device. "Ground truth" for this type of device is established through engineering and material science standards, and the expertise would lie with engineers and metallurgists involved in the design, manufacturing, and testing of the components.

4. Adjudication Method for the Test Set

Not applicable in the context of an AI/ML powered device. For mechanical strength, compliance with standards usually involves predefined measurement criteria and acceptance limits, rather than a human adjudication process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Malibu Spinal System is a physical implant, not an AI/powered device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Malibu Spinal System is based on engineering and material science standards, and performance benchmarks as established by predicate devices. The claim of substantial equivalence is based on the device's ability to meet the same mechanical strength, material composition, and functional design as previously cleared spinal fixation systems.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for a physical implant.

Summary

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OCT 2 5 2006

K06/342

CONFIDENTIAL

510(K) SUMMARY

Malibu™M

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.

Submitter Information:	SeaSpine, Inc.Contact: Diana Smith2302 La Mirada DriveVista, CA 92081-7862Phone: 760-727-8399 Fax: 760-727-8809
Company Registration Number:	2032593
Submission Correspondent:	SeaSpine, Inc.Contact: Diana Smith, Manager ofRegulatory Affairs and Quality Assurance2302 La Mirada DriveVista, CA 92081-7862Phone: 760-727-8399 Fax: 760-727-8809
Date Summary Prepared:	April 4, 2006
Classification Name:	Pedicle Screw Spinal SystemMNH (Class II) - 888.3070(b)(1)MNI (Class II) - 888.3070(b)(1)NKB (Class III) - 888.3070(b)(2)Spinal Interlaminal Fixation OrthosisKWP (Class II) - 888.3050
Common/Usual Name:	Cannulated polyaxial screws, closed lateralconnectors, rod connectors, precontouredrods, contoured crossbars, components, andinstruments
Device Trade Name:	Malibu™

The devices used for comparison in this summary are Synthes Spine Company's Synthes Click'X Monoaxial Screw System (K031175), DePuy Acromed's Moss Miami System (K002607 and K992168), and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/S1 and K043232) and Malibu Spinal System (K051663 and K051942).

Intended Use: (The statements of intended use are identical.)

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. degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
. severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
spondylolisthesis. ●
. trauma (i.e., fracture or dislocation),
spinal stenosis.
. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
. spinal tumor.
. pseudoarthrosis, and/or
failed previous fusion. .

The intended use and indications of the Malibu spinal system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

. degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis .
trauma (i.e., fracture or dislocation), �
. spinal stenosis.
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), ◆
. tumor,
pseudarthosis, and/or .
. failed previous fusion.

2. Description:

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with components in the UCR system. All product is supplied "NON-STERILE" and must be sterilized prior to use.

3. Technological Characteristics:

The cannulated polyaxial screws, closed lateral connectors, rod connectors, precontoured rods, contoured crossbars, components, and instruments in this notification are components being added to the previously cleared Malibu system, but are designed to be compatible with and work in conjunction with the components in the current SeaSpine UCR system. The devices in this submission have substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.

4. Comparison Analysis:

The overall designs of the cannulated polyaxial screws, closed lateral connectors, rod connectors, precontoured rods, contoured crossbars, and components are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the cannulated polyaxial screws, closed lateral connectors, rod connectors, precontoured rods, contoured crossbars, and components to the predicate devices.

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Malibu™

Feature	Malibu Spinal System	SynthesClick'XMonoaxialSystem	Moss MiamiSpinal System	SeaSpine UCRand MalibuSpinal Systems	SubstantiallyEquivalent
Intended Use	The intended use of theMalibu system is as atemporary or permanentposterior, non-cervicalimplant to correct spinaldisorders and providestabilization of the spine topermit the biologicalprocess of spinal fusions tooccur.	Similar	Similar	Similar	Yes
Indications forUse	Degenerative disc disease(DDD) as defined by backpain of discogenic originwith degeneration of thedisc confirmed by patienthistory and radiographicstudies,• spondylolisthesis,• trauma (i.e., fracture ordislocation),• spinal stenosis,• deformities or curvatures(i.e., scoliosis, kyphosis,and/or lordosis),• tumor,• pseudarthosis, and/or• failed previous fusion.	Similar	Similar	Similar	Yes
Design	Cannulated polyaxial screws,closed lateral connectors, rodconnectors, precontouredrods, contoured crossbars,and components.	Similar	Similar	Similar	Yes
CannulatedPolyaxialScrews	Various sizes	Similar	Similar	Similar	Yes
Closed LateralConnectors	Various sizes	Similar	Similar	NA	Yes
RodConnectors	Various sizes	Similar	Similar	NA	Yes
PrecontouredRods	Various sizes	Similar	Similar	Similar	Yes
ContouredCrossbars	Various sizes	Similar	Similar	Similar	Yes
Material	Titanium alloy, cobalt alloy	Similar	Similar	Similar	Yes
Sterile	Non-sterile	Similar	Similar	Similar	Yes
Method ofSterilization	High-temperature steam	Similar	Similar	Similar	Yes
MechanicalStrength	All products passed testingper applicable standards.	Similar	Similar	Similar	Yes

Table 1: Summary of Design Comparison

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular fashion around the symbol. The caduceus is rendered in a bold, black color, while the text is also in black but with a thinner font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SeaSpine, Inc. % Ms. Ethel Bernal Document Control Specialist 2302 La Miranda Drive Vista, California 92081

OCT 2 5 2006

Re: K061342

Trade/Device Name: Malibu Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Fixation System Regulatory Class: III Product Code: NKB, MNH, MNI, KWP Dated: September 5, 2006 Received: October 10, 2006

Dear Ms. Bernal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Ethel Bernal

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chabane Buchm

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: Malibu

Indications for Use:

The intended use of the Malibu spinal system is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally . mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
spondylolisthesis. .
trauma (i.e., fracture or dislocation), ●
spinal stenosis, .
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .

AND/OR

. spinal tumor,
pseudoarthrosis, and/or .
failed previous fusion. .

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED).

(Division Sign-Off)	Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,	Indications for Use Statement continued

and Neurological Devices

510(k) Number

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The intended use and indications of the Malibu spinal system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis .
trauma (i.e., fracture or dislocation), .
spinal stenosis, .
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
tumor, .
pseudarthosis, and/or .
failed previous fusion. .

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).

	Barbara Buchun
	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of General, Restorative,
	and Neurological Devices
510(k) Number	K011342

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.